What side effects are associated with this type of intervention?

Common side effects of treatments for Germ Cell Tumors, particularly those similar to ATLCAR.CD30, include cytokine release syndrome (CRS) with symptoms like fever, nausea, headache, rash, rapid heartbeat, low blood pressure, and trouble breathing. Neurotoxicity is also a significant side effect, potentially causing confusion, difficulty speaking, seizures, and loss of consciousness. Other side effects include cytopenias (low blood cell counts), infections, and infusion-related reactions.

What prior FDA approvals exist?

There is limited specific information on FDA-approved CAR-T cell therapies for Germ Cell Tumors. However, CAR-T cell therapies have been approved for other types of cancers, such as B-cell lymphomas and acute lymphoblastic leukemia. These therapies, like Kymriah (tisagenlecleucel) and Yescarta (axicabtagene ciloleucel), involve modifying a patient's T cells to target specific antigens on cancer cells. The ATLCAR.CD30 trial for CD30+ Nonseminomatous Germ Cell Tumors is exploring a similar approach by targeting the CD30 antigen, which is a novel application in this context.

What other types of research exist?

Promising novel alternatives to ATLCAR.CD30 for Germ Cell Tumors patients include: 1) CAR-T therapies targeting other antigens, such as CD19 or BCMA, which have shown efficacy in other cancers and may be adapted for GCTs. 2) Immune checkpoint inhibitors like pembrolizumab and nivolumab, which have demonstrated success in various solid tumors. 3) Bispecific T-cell engagers (BiTEs) that can direct T-cells to target tumor cells more effectively. 4) Personalized cancer vaccines that stimulate the immune system to attack cancer cells. These alternatives are being actively researched and may offer new hope for GCT patients in 2024.

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CAR T-cell Therapy

CD30 CAR T-Cells for Testicular Cancer

Phase 2

Recruiting

Led By Matthew I Milowsky

Research Sponsored by UNC Lineberger Comprehensive Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥ 18 years at the time of consent.

Histologically confirmed diagnosis of Nonseminomatous Germ Cell Tumors (NSGCT) of any primary site.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new treatment to fight certain types of cancer in adults. The treatment aims to improve how the body targets and kills cancer cells. Researchers will collect samples to see how well the treatment works and lasts in the body.

Who is the study for?

Adults over 18 with Nonseminomatous Germ Cell Tumors (NSGCT) who've had at least one prior treatment can join. They must show tumor growth or elevated cancer markers after high-dose chemo. Pregnant women, those breastfeeding, and individuals with active HIV, HTLV, hepatitis B or C are excluded.

What is being tested?

The trial is testing ATLCAR.CD30 Cells combined with Cyclophosphamide and Fludarabine in patients with NSGCT. It's a phase 2 study to see if modified T cells from the patient's blood can fight cancer more effectively when combined with antibodies.

What are the potential side effects?

Potential side effects may include immune reactions due to modified T cells attacking the body’s own tissues, as well as typical chemotherapy-related issues like nausea, fatigue, hair loss, and increased infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Select...

My cancer is a type of germ cell tumor that is not seminoma.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The Overall response rate (ORR)- Response Evaluation Criteria In Solid Tumors Criteria (RECIST)

Secondary study objectives

Adverse Events CTCAE

Cytokine Release Syndrome (CRS)

Duration of response (DOR)

+8 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: ATLCAR.CD30Experimental Treatment3 Interventions

Single Group Assignment: Subjects with Nonseminomatous Germ Cell Tumors who meet eligibility criteria for cellular therapy.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cyclophosphamid

2021

Completed Phase 2

~50

Fludarabine

2012

Completed Phase 4

~1830

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Germ Cell Tumors (GCTs) include chemotherapy, surgery, and radiation therapy. Chemotherapy works by using drugs to kill rapidly dividing cancer cells, while surgery involves physically removing the tumor, and radiation therapy uses high-energy rays to destroy cancer cells. A novel treatment similar to ATLCAR.CD30 is CAR T-cell therapy, which involves modifying a patient's T cells to express a chimeric antigen receptor that specifically targets tumor cells expressing the CD30 antigen. This approach combines the specificity of antibodies with the cytotoxic power of T cells, offering a targeted and potent treatment option. For GCT patients, these mechanisms are crucial as they provide multiple avenues to attack the tumor, potentially leading to better outcomes and reduced recurrence rates.